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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K981396
Device Name PYLORIPROBE
Applicant
Amdl, Inc.
14272 Franklin Ave., #106
Tustin,  CA  92680
Applicant Contact THAT T NGO
Correspondent
Amdl, Inc.
14272 Franklin Ave., #106
Tustin,  CA  92680
Correspondent Contact THAT T NGO
Regulation Number866.3110
Classification Product Code
LYR  
Date Received04/17/1998
Decision Date 07/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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